Ipsen’s third phase trial of Somatuline lead to Japan’s clearance for new indication, certain tumors

Ipsen’s partner Teijin Pharma Limited, has received approval from the Japanese Ministry of Health, Labour and Welfare for Ipsen’s subcutaneous drug Somatuline (lanreotide) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP NET).

To remind, the drug is approved in Japan for the treatment of acromegaly and pituitary gigantism since 2012.

The request for the additional approval was filed in July 2016, based on Ipsen’s investigational, pivotal phase III randomised placebo-controlled trial (CLARINET) in 204 patients with GEP NET conducted in 14 countries, and an open-label single group multicenter Phase II trial (J-001) in 32 patients with NET that Teijin Pharma conducted in Japan. This approval establishes Somatuline as the first drug available in Japan for the treatment of pancreatic NET.

Harout Semerjian, Executive Vice-President & President, Specialty Care International & Global Franchises said: “In line with our commitment to serve NET patients worldwide, this is a significant step after our partner Teijin launched Somatuline for the treatment of acromegaly and pituitary gigantism in Japan in January 2013.”

Akihisa Nabeshima, President of Teijin Pharma added: “It is our great pleasure to now have the capacity to provide a new therapeutic option to NET patients in Japan. We will continue to focus on drug discovery and improve the quality of life of patients by offering them new treatment options to fulfill unmet medical needs.”

About Neuroendocrine Tumors

NETs are malignant tumors arising from neuroendocrine cells. Most of the NET tumors present with metastasis and are discovered fortuitously. In some patients, excess hormones secreted from a NET can lead to severe diarrhea, peptic ulcers or hypoglycemia. While incidence rates are relatively rare, at about 3.5 gastrointestinal NET patients and 1.3 pancreatic NET patients per 100,000 people in Japan, the number of patients has been increasing year by year due to disease awareness and better diagnosis1.

The primary treatment for NETs is removal by surgery, but if this is not possible as the disease is usually disseminated, or if a tumor relapses following surgery, another option is a medical treatment, Ipsen explained